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Amgen Submits Application for Biosimilar Version of Humira (adalimumab)

Amgen today announced the submission of its first biosimilar application to FDA. The application seeks approval for a biosimilar version of Humira®(adalimumab). As we’ve covered extensively, Amgen is the biologic reference product sponsor and plaintiff in a number of BPCIA cases: Amgen v. Sandoz, Amgen v. Hospira, and Amgen v. Apotex.  This is the first time Amgen has formally appeared on…

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Roundup of Upcoming BPCIA Cases

As we have written about extensively, here, here, and here, the Federal Circuit recently interpreted two key provisions of the BPCIA in Amgen v. Sandoz. Three cases currently pending before District Courts raise related issues and each have the potential to reach the Federal Circuit. In this post, we provide…

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Apotex opposes Amgen’s motion for PI

On Friday, November 16, 2015, Apotex filed its brief in opposition to Amgen’s motion for a preliminary injunction in Amgen v. Apotex.  As we’ve discussed previously here, Amgen has moved to enjoin Apotex from marketing its yet-to-be-approved Neulasta biosimilar until at least 180 days after FDA approval.  Amgen has taken…

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Supplemental Scheduling Order Issued In Amgen v. Apotex

Yesterday Judge Cohn issued a supplemental scheduling order in Amgen v. Apotex.  The hearing for Amgen’s Motion for Preliminary Injunction has been rescheduled for December 3, 2015.  Claim construction briefing will occur in December and January, and the claim construction hearing will be held on February 5, 2016.  Expert reports…

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